Back to resultsSMART Trial: Community Stigma Reduction
Primary Purpose
Opioid-use Disorder, Stigma, Social
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opioid Use Disorder Stigma Reduction
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder focused on measuring stigma, opioid use disorder, community
Eligibility Criteria
Inclusion Criteria:
- Identify as African American or Mixed race
- Reside in Frayser or Orange Mound Communities
- Access to telephone for follow-up assessment
Exclusion Criteria:
- Unable to understand consent procedures
Sites / Locations
- University of Tennessee Health Science Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Participants who live in the Orange Mound community of Memphis. Billboards targeting stigma reduction were posted in the community for one month.
Participants who live in the Frayser community of Memphis. No billboards (intervention) were placed here.
Outcomes
Primary Outcome Measures
Stigma score
Pre- and post-intervention stigma assessments using the Exposure to Drug Users Index, Drug Use Stigmatization Scale, and the Stigma of Drug Users Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT05075330
First Posted
September 14, 2021
Last Updated
March 3, 2022
Sponsor
Karen Derefinko, PhD
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT05075330
Brief Title
SMART Trial: Community Stigma Reduction
Official Title
SMART Trial: Reducing Stigma Towards Opioid Use Disorder at the Community Level
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
August 19, 2021 (Actual)
Study Completion Date
August 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karen Derefinko, PhD
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this project is to engage community members from two low-income African American communities (N=200) in a survey study that assesses stigma toward those with Opioid Use Disorder (OUD). Those from the intervention community will be subject to a stigma reduction campaign via billboards. Those from the control community will not. Stigma will be re-assessed following the period of the campaign.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Stigma, Social
Keywords
stigma, opioid use disorder, community
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants assigned to intervention or control based on zip code of primary residence.
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
199 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants who live in the Orange Mound community of Memphis. Billboards targeting stigma reduction were posted in the community for one month.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants who live in the Frayser community of Memphis. No billboards (intervention) were placed here.
Intervention Type
Behavioral
Intervention Name(s)
Opioid Use Disorder Stigma Reduction
Intervention Description
Billboards with destigmatizing language regarding opioid use disorder placed in the community.
Primary Outcome Measure Information:
Title
Stigma score
Description
Pre- and post-intervention stigma assessments using the Exposure to Drug Users Index, Drug Use Stigmatization Scale, and the Stigma of Drug Users Scale
Time Frame
Change from baseline stigma score at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Identify as African American or Mixed race
Reside in Frayser or Orange Mound Communities
Access to telephone for follow-up assessment
Exclusion Criteria:
Unable to understand consent procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Derefinko, PhD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
Available by end of 2021.
Learn more about this trial
SMART Trial: Community Stigma Reduction
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